Senior Director Clinical Operations - Home Based (US)
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Senior Director, Clinical Operations is a senior leadership position responsible for the strategic planning, tactical execution, and day-to-day management of clinical investigations involving human subjects. The role ensures compliance with corporate objectives, regulatory requirements, and global standards such as ICH-GCP, Good Clinical Practice, and local regulations
Primary Functions- Strategic & Operational Leadership: Develop and execute accurate operational development plans for assigned clinical trials, aligning with budget, timelines, and standard operating procedures (SOPs)
- Trial Management: Oversee the management of clinical studies, including compliance with corporate, regulatory, and quality standards.
- Team & Vendor Oversight: Lead clinical operations personnel, contract research organizations (CROs), consultants, core laboratories, and other study support organizations.
- Program-Level Responsibilities: Handle program-level activities as assigned, ensuring operational plans are implemented effectively.
- Compliance & Quality: Ensure adherence to ICH-GCP, GPP, Incyte SOPs, and applicable country-specific regulations.
- Collaboration: Work cross-functionally with internal teams (e.g., Medical Affairs, Medical Science Liaisons, Medical) and external partners to support trial goals and timelines.
Key responsibilities include:
- Accountable for the development and execution of operational plans for direct trial responsibilities.
- Manage recruitment, completion, and budgeting of R&D-sponsored trials within timelines.
- Oversee local CRAs and vendor oversight for sponsored trials.
- Plan and execute clinical trial goals, ensuring compliance with quality and timelines.
- Represent local regions in global study team meetings, providing feedback and insights.
- Ensure timely submission and approval of ethical and administrative submissions for in-house studies.
- Monitor site performance, feasibility, and study execution for assigned trials.
Your Profile:You will bring significant clinical operations experience, with a track record of building high-performing teams and delivering results.
Required qualifications and experience:
- Bachelor's degree in life sciences or related field; advanced degree preferred.
- Extensive experience in clinical operations within the pharmaceutical, biotechnology, or CRO industry.
- Ability to manage complex, multi-site trials across global regions.
- Proven track record of successfully leading and managing clinical trials from start to finish.
- Strong understanding of regulatory requirements and GCP guidelines.
- Excellent communication, leadership, and problem-solving skills.
- Willingness to travel as required (approximately 20%)
- To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status
Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
